TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas
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|ClinicalTrials.gov Identifier: NCT04335357|
Recruitment Status : Not yet recruiting
First Posted : April 6, 2020
Last Update Posted : April 6, 2020
Information provided by (Responsible Party):
This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, efficacy, PK, and PD of the chimeric dopamine-somatostatin receptor agonist, TBR-760, in adult patients with NFPA over 52 weeks.
|Condition or disease||Intervention/treatment||Phase|
|Non-Functional Pituitary Adenoma Pituitary Tumor, Nonfunctioning||Drug: TBR-760 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blind placebo controlled|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Double blind placebo controlled|
|Official Title:||A One Year, Randomized, Double-Blind, Placebo-Controlled Study of TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas|
|Estimated Study Start Date :||May 2020|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||June 2023|
Placebo Comparator: placebo
The appearance and fill of placebo syringes will be identical to the active comparator.
Active Comparator: TBR-760
TBR-760 is supplied as a ready-to-use solution in pre-filled syringes at a concentration of 5 mg/ml.
TBR-760 is intended for SC administration. The target dose to be studied in this study is 6 mg SC given once weekly.
Primary Outcome Measures :
- tumor volume reduction [ Time Frame: 52 weeks ]the primary efficacy endpoint is the percentage of patients with tumor volume reduction
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